Full thickness resectioning device

ABSTRACT

A full thickness resection device comprises a control handle including an actuator wherein, when the device is in an operative position within a body lumen of a patient, the control handle remains outside the patient&#39;s body and a working head assembly coupled to a control handle by a flexible sheath, wherein, when the device is in the operative position; the working head assembly is located within a body lumen of the patient adjacent to a portion of tissue to be treated, the working head assembly including a tissue stapling mechanism including first and second tissue stapling members moveable relative to one another in combination with a first cable extending from the actuator through the flexible sheath to the first tissue stapling member so that, when the actuator is operated to draw the first cable proximally from the sheath, the first tissue stapling member is moved in a first direction relative to the second tissue stapling member.

BACKGROUND INFORMATION

Full thickness resection procedures involve excising a full thicknessportion of an organ, closing the hole created by the resection andremoving the excess tissue.

Several known full thickness resection devices and procedures require atleast one incision in an area near a portion of an organ to be excisedto allow the physician to access the organ section to be excised andguide the device to that section. Those skilled in the art willunderstand that these incisions may add substantially to the patientdiscomfort and recovery time associated with the resectioning procedureitself.

SUMMARY OF THE INVENTION

The present invention is directed to a full thickness resection devicecomprising a control handle including an actuator wherein, when thedevice is in an operative position within a body lumen of a patient, thecontrol handle remains outside the patient's body and a working headassembly coupled to a control handle by a flexible sheath, wherein, whenthe device is in the operative position; the working head assembly islocated within a body lumen of the patient adjacent to a portion oftissue to be treated, the working head assembly including a tissuestapling mechanism including first and second tissue stapling membersmoveable relative to one another in combination with a firsttransmission member extending from the actuator through the flexiblesheath to the first tissue stapling member so that, when thetransmission member is operated, the first tissue stapling member ismoved in a first direction relative to the second tissue staplingmember.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of a full thickness resection deviceaccording to a first embodiment of the present invention;

FIG. 2 shows a perspective view of a working head assembly of the deviceof FIG. 1;

FIG. 3a shows a cross-sectional view of the working head assembly ofFIG. 2 with the anvil member in a closed position;

FIG. 3b shows a cross-sectional view of the working head assembly ofFIG. 2 with the anvil member in an open, tissue receiving position;

FIG. 3c shows a side view of the mounting shaft of FIGS. 3a and 3 b;

FIG. 3d shows a partially cross-sectional view of the working headassembly of FIGS. 3a and 3 b with a more detailed view of the stopsurfaces of the housing;

FIG. 4 shows a perspective view of a full thickness resection deviceaccording to a second embodiment of the invention;

FIG. 5a shows a cross-sectional view of the working head assembly ofFIG. 4 with the anvil member in a closed position;

FIG. 5b shows a cross-sectional view of the working head assembly ofFIG. 4 with the anvil member in an open, tissue receiving position;

FIG. 6 shows a perspective view of a full thickness resection deviceaccording to a third embodiment of the invention;

FIG. 7 shows a portion of a drive mechanism according to a fourthembodiment of the invention; and

FIG. 8 shows a portion of a drive mechanism according to a fifthembodiment of the invention.

DETAILED DESCRIPTION

The present invention comprises a system for full thickness resection oftissue from within a body lumen including many features substantiallysimilar to those described in U.S. patent application Ser. No.09/694,894, filed Oct. 25, 2000 and entitled Method and Device for FullThickness Resectioning of an Organ, the entire disclosure of which ishereby expressly incorporated by reference (“the '894 application).Those skilled in the art will understand that the working head assembly2 described below may be constructed substantially in accord with any ofthe embodiments described in the '894 application except for thefeatures specifically detailed below. Each of the embodiments describedbelow reduces the length of the working head assembly required toenclose the drive mechanism for a tissue stapling apparatus.

As shown in FIGS. 1-3, an apparatus according to a first embodiment ofthe present invention comprises a working head assembly 2 which maypreferably be connected to a distal end 4 a of a sheath 4. The proximalend 4b of the sheath 4 may preferably be connected to a control handle 6which remains outside the patient's body during operation.

In operation, the entire apparatus is mounted onto an endoscope 8 bypassing the endoscope 8 through the control handle 6, the sheath 4, andthrough an endoscope receiving channel 9 in the working head assembly 2,as shown in FIGS. 1 and 2. The endoscope 8 is then inserted into anorgan via a body orifice to locate a lesion under visual observation(usually while insufflating the organ). The organ may, for example, be asubstantially tubular organ such as the colon. Once the lesion has beenlocated, the working head assembly 2 and the sheath 4 are slidablyadvanced along the endoscope 8 into the organ until the working headassembly 2 is in a desired position adjacent to the lesion. Thoseskilled in the art will understand that a device according to thepresent invention may also be inserted into a body lumen via asurgically created opening.

As shown in FIG. 2, the working head assembly 2 comprises an anvilmember 10 coupled to a distal end 12 a of a housing 12 with a proximalcap 14 coupled to a proximal end 12 a of the housing. A staple firingmechanism 16 is mounted in the distal end 12 a so that staples firedtherefrom are directed toward a staple-forming surface 10 a on aproximal side of the anvil member 10. Those skilled in the art willunderstand that various working head assembly/anvil profiles may beemployed depending on the desired line of tissue stapling and cuttingfor a particular application.

A drive mechanism (described more fully below) moves the anvil member 10relative to the staple firing mechanism 16 between a first position inwhich the anvil member 10 is separated from the distal end 12 a by apredetermined tissue-receiving distance and a second position in whichthe anvil member 10 is separated from the distal end 12 a by a desiredstapling distance which is less than the tissue-receiving distance.Those skilled in the art will understand that, for insertion of thedevice into and retraction of the device from the body lumen, the drivemechanism may also move the anvil member 10 relative to the distal end12 a to a fully closed position in which the proximal side of the anvilmember 10 contacts the distal end 12 a. The drive mechanism according tothe present invention allows the axial length of the working headassembly 2 to be reduced, thereby improving device mobility and allowingthe device to be utilized in areas beyond the reach of larger, lessmobile FTRD devices.

Specifically, as shown in FIG. 2, when in the tissue receiving position,the anvil member 10 is separated from the distal end 12 a by a gapsufficiently large to allow the operator to draw the lesion to beresected thereinto. When the tissue to be resected has been drawn intothe gap between the anvil member 10 and the distal end 12 a, theoperator actuates the drive mechanism to move the anvil member 10 into adesired stapling position in which the anvil member 10 is separated fromthe distal end 12 a by a gap the size of which is selected based on thecharacteristics of the staples to be used and the staple forming resultsdesired by the operator. Thus, those skilled in the art will understandthat the size of this gap may vary depending on the particularapplication for which the device is designed or, alternatively, may beadjustable by an operator utilizing known staple gap adjustmentmechanisms. In the illustrative embodiment shown in FIGS. 3a and 3 b,the minimum gap size is controlled by shoulder members 12 c whichproject distally from the distal end 12 a. Thus, when the anvil member10 is moved proximally, a proximal face of the anvil member 10 contactsthe shoulder members 12 c when the distance between the staple formingsurface 10 a and the distal end 12 a is the desired stapling distance.In this case, the stapling position is the same as the fully closedposition.

As shown in FIGS. 2, 3 a and 3 b, the anvil member 10 according to thefirst illustrative embodiment is coupled to the housing 12 by means oftwo mounting shafts 28 which are slidably received through correspondingmounting shaft channels 30. Each of the shafts 28 includes a centralchannel 32 extending therethrough with a compression spring 34 receivedtherein abutting a corresponding spring stop 36 mounted at the proximalend of each of the shaft channels 30. The distal end of each of thesprings 34 abuts an inner surface at the distal end of the correspondingcentral channel 32. Thus, the compression springs 34 bias the anvilmember 10 distally away from the distal end 12 a of the housing 12.Those skilled in the art will understand that the length of the centralchannels 32 and the springs 34 should be selected so that, whenreleased, the anvil member 10 is moved distally by the springs 34 awayfrom the distal end 12 a to a distance at least equal to the desiredtissue receiving gap. In addition, as shown in FIGS. 3c and 3 d, anabutting surface 38 may be formed on one or both of the shafts 28 forcontacting a corresponding stop surface 40 extending from the housinginto the corresponding shaft channel 30 to prevent the anvil member 10from moving away from the distal end 12 a beyond the maximum desiredtissue receiving gap.

An anvil control cable 42 is formed as a loop extending from a distalend of a first one of the shafts 28 to which it is coupled, through thecorresponding shaft channel 30 and central channel 32 and through theworking head assembly 2 proximally into the sheath 4 to pass distallythrough the sheath 4 to the control handle 6. The loop of the cable 42extends back through the sheath 4, into the working head assembly 2 tothe other shaft 28 via the corresponding shaft channel 30 and centralchannel 32 to couple to the distal end of that shaft 28. Specifically,the anvil control cable 42 is coupled to the distal ends of each of thecontrol shafts 28 which are coupled to the anvil member 10 and passes asa loop through the sheath 4 to a control cable actuator (not shown) onthe control handle 6. Thus, actuating the control cable actuator pullsthe loop of the anvil control cable 42 proximally, drawing the anvilmember 10 proximally relative to the distal end 12 a against the bias ofthe springs 34. Those skilled in the art will understand that,alternatively, the loop of the anvil control cable 42 may be formed astwo separate cables or as a single cable to achieve the same operation.Furthermore, those skilled in the art will understand that the anvilmember 10 may be coupled to the housing 12 by a single shaft 28 ifdesired. However, such a design may provide decreased rigidity.

Thus, actuating the control cable actuator to withdraw the cable(s) 42proximally from the device while maintaining the position of the workinghead assembly 2 constant, draws the anvil member 10 proximally towardthe distal end 12 a of the housing 12. Those skilled in the art willunderstand that the length of the shaft channels 30, the centralchannels 32, the guide shafts 30 and the springs 34 should also beselected so that, when the control cable 42 has been withdrawnproximally a maximum distance, the anvil member 10 is moved proximallyagainst the bias of the springs 34 toward the distal end 12 a until theanvil member 10 and the distal end 12 a are separated by a distanceequal to the desired tissue stapling gap. Alternatively, as describedabove, these components may be designed so that the anvil member 10 maybe drawn toward the distal end 12 a until the anvil member 10 and theshoulder members 12 c are in contact with one another (e.g., a fullyclosed position for insertion and retraction of the device). Asdescribed above, in this embodiment, the stapling position and the fullyclosed position are the same. As shown in FIGS. 2, 3 a and 3 b, thethickness of the shoulder members 12 c determines the size of thestapling gap. For example, a gap of approximately 0.070″ may beemployed. However, a separate stapling gap adjusting mechanism may beemployed as would be understood by those of skill in the art (e.g., byadjusting the position of the spring stop 36). Furthermore, as would beunderstood by those of skill in the art, a locking mechanism (not shown)may be included in the control cable actuator to allow a user to lockthe cable(s) 42 in a desired position so that a separation of the anvilmember 10 and the distal end 12 a is held at any desired size.

The compression springs 34 may preferably be formed of stainless steel(e.g., music wire) and should supply a sufficient biasing force toensure that the anvil member 10 will achieve the desired tissuereceiving gap upon release of the control cable actuator, overcoming,for example, any friction resisting distal movement of the shafts 28and/or the cable(s) 42. For example, a total force of approximately 8 to12 lbs. and, more preferably approximately 10 lbs., may be sufficient toachieve the preferred tissue receiving gap of 0.75 inches. Thus, each ofthe springs 34 may, when the anvil member 10 is in the tissue staplingposition, have been compressed to the point that a 5 lb. force isapplied between the corresponding spring stop 36 and the distal end ofthe respective central channel 32. For example, a suitable spring foruse as the spring 34, may comprise a music wire coil spring with adiameter of, e.g., 0.15 inches with a free length of 1.50 inches such asthe commercially available Lee Spring LC-023-AB-14.

As shown in FIGS. 4, 5 a and 5 b, a working head assembly 2′ accordingto a second embodiment of the invention is substantially similar to thatof the previously described embodiment except for the drive mechanismwhich will be described below. The working head assembly 2′ includes ananvil member 10 coupled to the distal end 12 a of the working headassembly 2′ by two shafts 28 received into the working head assembly 2′within corresponding shaft channels 30 as described above in regard toFIGS. 1-3. However, in this embodiment, control cable loops 46 arecoupled to the shafts 28, by for example, screws 49 and extend throughthe sheath 4 to a control cable actuator (not shown) as described abovein regard to the control cable 42 of the embodiment shown in FIGS. 1-3.Each of the control cable loops 46 extends from the screw 49, throughthe corresponding shaft 28, around a pulley 52 back through the workinghead assembly 2′ and the sheath 4 to the control cable actuator as willbe described in more detail below. Each of the ends of the cable loops46 pass through the proximal cap 14 and through a cable routing plate 51to couple to the corresponding shaft 28.

As shown in FIGS. 5a and 5 b, the control cable 46 extends from thecontrol cable actuator (not shown), through the sheath 4 to the workinghead assembly 2′ and is connected to the shaft 28 by a screw 49. Thecontrol cable 46 extends from the screw 49 out of the shaft 28 andpasses around a pulley 52 to pass out of the working head assembly 2′and through the sheath 4 to the control cable actuator. As would beunderstood by those of skill in the art, the control cable actuator isdesigned so that, portions of the cable 46 on opposite sides of thepulley 52 move in opposite directions when the actuator is operated.Each of the pulleys 52 is located distally of the point at which thecable 46 exits the shaft 28 so that, when the control cable actuator ismoved so that the cable 46 withdraws the screw 49 and the shaft 28proximally, the anvil member 10 is moved proximally toward the distalend 12 a of the housing 12. Operating the control cable actuator in theopposite direction draws the control cable 46 and the correspondingscrew 49 distally so that the shaft 28 and the anvil member 10 are moveddistally away from the distal end 12 a.

As shown in FIG. 6, a working head assembly 2″ according to a thirdembodiment of the invention is substantially similar to the previouslydescribed embodiments except for the a drive mechanism for moving theanvil member 10 relative to the distal end 12 a of the housing 12.Specifically, the drive mechanism of the working head assembly 2″includes an axially flexible, substantially torsionally rigid driveshaft 60 including a threaded distal end 60 a which engages a matingthread in a channel 64 extending within a first one of the shafts 28′.The first shaft 28′ is coupled to the second of the shafts 28″ by a yokemember 66. The first shaft 28′ is prevented from rotation relative tothe housing 12 by, for example, a projection therefrom fitting into acorresponding recess in the respective shaft channel 30. Thus, as thedrive shaft 60 is rotated in a first direction relative to the firstshaft 28′, the first shaft 28′, the yoke member 66 and the second shaft28″ are advanced distally into the housing 12 and the anvil member 10 ismoved distally away from the distal end 12 a. When the drive shaft 60 isrotated in a second direction opposite to the first direction, the firstshaft 28′, the yoke member 66 and the second shaft 28″ are withdrawnproximally into the housing 12 and the anvil member 10 is drawn towardthe distal end 12 a.

FIG. 7 shows a fourth embodiment of a drive mechanism according to thepresent invention which is substantially similar to the previouslydescribed embodiments except for the a drive mechanism for moving theanvil member 10 relative to the distal end 12 a of the housing 12. Thedrive mechanism of FIG. 7 includes a drive shaft 60 having, for example,a screw member (not shown) mounted thereto. The screw member is receivedwithin an idler gear 72 for rotation therewith. The idler gear 72 mesheswith gears 74 to rotate shafts 76 which are mounted thereto. Each of theshafts 76 includes a threaded distal portion 76 a which engages a matingthread in channels of the shafts 28 (as described above for the matingof shaft 28′ and the threaded portion 60 a). Thus, upon rotation of thedrive shaft 60, the idler gear 72 rotates the gears 74, the shafts 76and the threaded portions 76 a to move the shafts 28 and the anvilmember 10 toward and away from the distal end 12 a of the housing 12.

FIG. 8 shows a fifth embodiment of a drive mechanism according to thepresent invention which is substantially similar to the drive mechanismof the fourth embodiment and the previously described embodiments exceptfor the drive mechanism for moving the anvil member 10 relative to thedistal end 12 a of the housing 12. The drive mechanism of FIG. 8includes a drive shaft 60 having a screw member (not shown) mountedthereto. The screw member is received within a first gear 80 forrotation therewith. The first geared shaft 80 meshes with an idler gear82 to rotate a second gear 84. Rotation of each of the first and secondgears 80, 84, in turn, rotates a corresponding one of the shafts 86mounted thereto. Each of the shafts 86 includes a threaded distalportion 86a which engages a mating thread in a channel of acorresponding one of the shafts 28 (as described above for the mating ofshafts 28 and the shafts 74). Thus, upon rotation of the drive shaft 60,the screw member rotates the gear 80, thereby rotating the idler gear 82and the second gear 84 which rotates the shafts 86 and the threadedportions 86a within the shafts 28 to move the anvil member 10 toward andaway from the distal end 12 a.

The above described embodiments are for purposes of illustration onlyand the various modifications of these embodiments which will beapparent are considered to be within the scope of the teachings of thisinvention which is to be limited only by the claims appended hereto.

What is claimed is:
 1. A full thickness resection device comprising: acontrol handle including an actuator wherein, when the device is in anoperative position within a body lumen of a patient, the control handleremains outside the patient's body; a working head assembly coupled to acontrol handle by a flexible sheath, wherein, when the device is in theoperative position, the working head assembly is located within a bodylumen of the patient adjacent to a portion of tissue to be treated, theworking head assembly including a tissue stapling mechanism includingfirst and second tissue stapling members moveable relative to oneanother; a first cable extending from the actuator through the flexiblesheath to the first tissue stapling member so that, when the actuator isoperated to draw the first cable proximally from the sheath, the firsttissue stapling member is moved in a first direction relative to thesecond tissue stapling member; and a second cable extending from thefirst tissue stapling member to the control handle so that, when thesecond cable is drawn proximally from the sheath, the first tissuestapling member is moved relative to the second tissue stapling memberin a second direction opposite to the first direction.
 2. The deviceaccording to claim 1, wherein the first tissue stapling member is ananvil and the second tissue stapling member is a staple firing mechanismand wherein the second cable extends around a pulley to couple to theanvil, so that, when the second cable is drawn proximally from thesheath, the anvil is moved distally relative to the staple firingmechanism.
 3. The device according to claim 2, wherein the anvil ismounted to a shaft which is slidably coupled to the working headassembly and wherein the second cable is coupled to the shaft.
 4. Thedevice according to claim 2, wherein the anvil is coupled to a shaftslidably received within the working head assembly and wherein the firstcable extends from a distal end of the shaft, through the sheath to theactuator so that, drawing the first cable proximally from the sheathdraws the anvil proximally relative to the staple firing mechanism. 5.The device according to claim 1, further comprising a resilient memberbiasing the first tissue stapling member relative to the second tissuestapling member in a second direction opposite to the first direction sothat, when no force is applied to the first cable, the first tissuestapling member is moved in the second direction relative to the secondtissue stapling member.
 6. The device according to claim 5, wherein thefirst tissue stapling member is an anvil and the second tissue staplingmember is a staple firing mechanism.
 7. The device according to claim 6,wherein the anvil is mounted to a shaft which is slidably coupled to theworking head assembly and wherein the resilient member is a springcoupled between the shaft and the working head assembly.
 8. The deviceaccording to claim 1, further comprising a locking member on the controlhandle allowing an operator to lock the first and second tissue staplingmembers in a desired position relative to one another.
 9. A fullthickness resection device comprising: a control handle including anactuator wherein, when the device is in an operative position within abody lumen of a patient, the control handle remains outside thepatient's body; a working head assembly coupled to a control handle by aflexible sheath, wherein, when the device is in the operative position;the working head assembly is located within a body lumen of the patientadjacent to a portion of tissue to be treated, the working head assemblyincluding a tissue stapling mechanism including first and second tissuestapling members moveable relative to one another; a flexible driveshaft extending from the actuator through the flexible sheath to theworking head assembly; a first threaded member coupled to a distal endof the drive shaft for rotation therewith; and a first mounting barcoupled to the first tissue stapling member and movably received withinthe working head assembly, the first mounting bar including a threadedchannel formed therein with the first threaded member received thereinso that rotation of the first threaded member within the threadedchannel moves the first mounting bar and the first member relative tothe second tissue stapling member.
 10. The device according to claim 9,wherein the first tissue stapling member is an anvil and the secondtissue stapling member is a staple firing mechanism.
 11. The deviceaccording to claim 10, wherein rotation of the drive shaft in a firstdirection moves the anvil away from the tissue stapling mechanism androtation of the drive shaft in a second direction opposite to the firstdirection moves the anvil toward the tissue stapling mechanism.
 12. Thedevice according to claim 9, wherein the first tissue stapling member isa staple firing mechanism and the second tissue stapling member is ananvil.
 13. The device according to claim 10, wherein the first threadedmember and the drive shaft are integrally formed.
 14. The deviceaccording to claim 10, further comprising a gearing mechanism coupledbetween the drive shaft and the first threaded member so that rotationof the drive shaft rotates the gearing mechanism which rotates the firstthreaded member.
 15. The device according to claim 14, furthercomprising a second mounting bar coupled to the first tissue staplingmember and movably received within the working head assembly.
 16. Thedevice according to claim 15, further comprising a second threadedmember received within a threaded channel formed within the secondmounting bar, the second threaded member being coupled to the firstthreaded member by a gearing mechanism so that rotation of the firstthreaded member rotates the gearing mechanism which rotates the secondthreaded member within the threaded channel of the second mounting bar.17. The device according to claim 15, wherein the drive shaft is coupledto the first and second threaded members by a gearing mechanism.
 18. Thedevice according to claim 10, further comprising a second mounting barcoupled to the first tissue stapling member and movably received withinthe working head assembly, the second mounting bar being coupled to thefirst mounting bar by a yoke member.
 19. The device according to claim10, further comprising a locking member on the control handle allowingan operator to lock the first and second tissue stapling members in adesired position relative to one another.